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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K223292
Device Name TempSure System
Applicant
Cynosure, LLC
5 Carlisle Rd.
Wesford,  MA  01886
Applicant Contact Michael King
Correspondent
Cynosure, LLC
5 Carlisle Rd.
Wesford,  MA  01886
Correspondent Contact Michael King
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
PBX  
Date Received10/26/2022
Decision Date 11/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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